Approval Order StatementApproval for the hires 90k mock-up as sterile instead of non-sterile, and to establish the shelf life at three years. The device, as modified, will be marketed under the trade name harmony hiresolution bionic ear system hires 90k mock-up (mock-up) and is indicated for individuals aged twelve months and older with severe-to profound sensorineural hearing loss via electrical stimulation of the auditory nerve.